IRB Survival Handbook

Biobanks

Specimen/Tissue/Data Registries: Comprehensive webpage that provides tools and information on Biospecimens, Biobanks, Data Registries, Genetic Research, GINA, Genomic Data Sharing, and Secondary Research. 

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Cancer Research

Resources for Cancer Research

• Markey Cancer Center/IRB/ORI Coordination SOP [C6.0400]
• NCI CIRB SOP (NIH Pediatrics Cooperative Group Trials) [C3.0400]

Children (including Wards of the State/Emancipated Individuals) (Vulnerable Subjects)

Research Involving Children: A comprehensive webpage that provides tools and information on Research Involving Children, Enrolling K-12 Students as Subjects, Parent Permission, Assent, Exemptions, Federally Mandated Categories, and Additional Regulatory Protections.

Clinical Trials

Clinical Trials: A comprehensive webpage that provides information on Clinical Research vs. Clinical Trials, What You Need to Know for Conducting Clinical Trials, UK ClinicalTrials.gov, Clinical Trial Consent Forms, and Clinical Trial Resources & Training

Community-Engaged/Participatory Research

Community-Engaged and Community-Based Participatory Research Frequently Asked Questions [D115.0000]: A comprehensive webpage that provides information on Community-Based Participatory Research.

Concerns, Suggestions, or Questions: IRB/ORI Administrative Process; Investigator Appeals; Subject Concerns

Resources for concerns, suggestions, and questions about IRB/ORI Administrative Processes; Investigator Appeals; Subject Concerns.

• Contact ORI
• Subject Concerns/Complaints SOP [C2.0500]
• Noncompliance SOP [C2.0550]

Confidentiality & Privacy

Confidentiality/Privacy in Research: A comprehensive webpage that provides information on Confidentiality, Certificates of Confidentiality, and Privacy in Research.

See also: Data Security

Conflict of Interest/Significant Financial Interest

• DHHS Financial Conflict of Interest Guidance: Financial Relationships and Interests in Research Involving Human Subjects [D73.0000]
• IRB Member Conflict of Interest:
  • IRB Member and Consultant Conflict of Interest SOP [C1.0200]
  • IRB Member Conflict of Interest Statement [F17.0000] (PDF)
  • Consultant Conflict of Interest Statement and Confidentiality Agreement (PDF)
• Investigator Conflict of Interest
  • UK Administrative Regulations (AR) 7:2 Financial Conflicts of Interest in Research
  • Investigator Conflict of Interest/OSPA/IRB Coordination SOP [C6.0650]
  • UK Resources on Financial Conflict of Interest

Continuation Review/Annual Administrative Review

Continuation Review (CR)/Annual Administrative Review (AAR): A comprehensive webpage that provides additional tools and information on developing a Continuation Review application and the Continuation Review process.

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Data and Safety Monitoring

Resources for Data and Safety Monitoring: A comprehensive webpage that provides resources on data and safety monitoring.

Data Security

Data Security: A comprehensive webpage that provides data security information on Electronic Data, Honest Brokers, UK Information Technology Services Policies & Procedures, UK General Data Protection Regulations, HIPAA, Family Education Rights and Privacy Act (FERPA), Digital Data, and the Children Online Privacy Protection Act (COPPA).

Deception Research

Debriefing and Permission to Use Data Form [F1.0365]

Department Chair Responsibilities

Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.

Devices (Medical Devices, including Mobile Medical Devices/Software)

FDA-Regulated Research: A comprehensive webpage that provides tools and information on Medical Devices, Mobile Medical Devices/Software; Digital Health Policy; Compassionate Use, Humanitarian Use Device (HUD), Investigators Who Are Considered Sponsors, Investigational Device Exemptions (IDE), Nonsignificant Risk Device (NSR), and Food and Drug Administration (FDA) Resources.

Digital Technology and Internet Research

Digital Technology and Internet Research: A comprehensive webpage that provides information on digital technology and internet research. 

Drugs/Dietary Supplements

FDA-Regulated Research: A comprehensive webpage that provides tools and information on Medical Devices, Mobile Medical Devices/Software; Digital Health Policy; Compassionate Use, Humanitarian Use Device (HUD), Investigators Who Are Considered Sponsors, Investigational Device Exemptions (IDE), Nonsignificant Risk Device (NSR), and Food and Drug Administration (FDA) Resources.

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Economically or Educationally Disadvantaged Persons (Vulnerable Subjects)

Economic or Education Disadvantaged Persons: A webpage with information on research involving economically or educationally disadvantaged individuals.

Education & Training

Training & Education: A comprehensive webpage that provides information on training and education for Researchers, Research Staff, IRB Members, and Non-UK Study Personnel. 

Emergency Use and Expanded Access of FDA-Regulated Products

FDA Emergency Use/Expanded Access: A comprehensive webpage that provides information on Emergency Use and Expanded Access of FDA-regulated products.

Ethics

Ethics resources that pertain to human subject research:

• UK HealthCare Bioethics Program
• Belmont Report
• Declaration of Helsinki
• Nuremberg Code: Directives for Human Experimentation
• Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard Justice in Clinical Research [HTML], Toolkit [HTML], and Resources for IRBs/HRPPs to provide to Investigators/Research Teams [HTML] 

Exempt Review

Exempt Review: A comprehensive webpage that provides tools and information on Exempt Review.

Expedited Review

Expedited Review: A comprehensive webpage that provides tools and information on Expedited Review.  

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Faculty Advisor Responsibilities

Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.

FDA-Regulated Research

FDA-Regulated Research: A comprehensive webpage that provides tools and information on Food and Drug Administration (FDA) research.

Federal Agency Specific Requirements

Select Federal Agency Requirements: A comprehensive webpage that provides information on Department of Defense (DoD) Supported Human Research, Department of Education (DoE) Requirements, Department of Energy (DoE) Requirements, Environmental Protection Agency (EPA) Requirements, Department of Justice (DoJ) Requirements, National Institute of Justice (NIJ), Bureau of Prisons (BoP).

Federalwide Assurance (FWA)

Single IRB Reliance: See Basic Assurance Requirements and  Institutional Review Board (IRB) Authorization Agreement under “Sample Forms.”

Federal Regulations on Human Research

• Federal Regulation Tracker Interactive Tool [D86.0000]
• Food and Drug Administration (FDA) Resources [D116.0000] (PDF)
• Comparison of FDA and HHS Human Subject Protection Regulations (by FDA)
• Online Regulations Governing Human Subjects Research:
  • Department of Health and Human Services (HHS)
    • 45 CFR 46 ("The Common Rule" - Human Subject Protections)
    • Office for Human Research Protections (OHRP) Human Subject Regulations Decision Charts
    • NIH Guidance:
      • Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards):
        Notice Number: NOT-OD-12-130
      • Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
        Notice Number: NOT-OD-12-129
  • Food and Drug Administration (FDA)
    • 21 CFR 812 (Investigational Device Exemptions)
    • 21 CFR 312 (Investigational New Drugs)
    • 21 CFR 56 (Institutional Review Boards)
    • 21 CFR 50 (Protection of Human Subjects)

Full Review (Initial)

IRB Review Types: A comprehensive webpage that provides additional tools and information on Initial Full Review.

Funding

See “Human Subjects” on  NIH Office of Extramural Research (OCR).

Future Use, Sharing, Record Reviews and Secondary Research

• Primary Research & Future Use [Interactive Video]
• UK ORI Secondary Use Research Tool [Interactive Tool]
• UK Fact Sheet – Final NIH Policy for Data Management and Sharing
• Research Data Services at UK: Data Management and Sharing Plan
• UK ORI Record Reviews (PDF)

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HIPAA in Research

HIPAA in Research: Comprehensive webpage that provides additional tools and information on Covered Entities, HIPAA Identifiers, and Waiver of Authorization.

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Impaired Consent Capacity (inc. Legally Authorized Representatives) (Vulnerable Subjects)

Research Involving Adults with Impaired Consent Capacity - Comprehensive webpage that provides additional tools and information on research involving adults with impaired consent capacity.

• University of Kentucky Adults with Impaired Consent Capacity Policy [D62.0000] (PDF)
• Protection of Vulnerable Subjects SOP [C3.0100]
• Informed Consent SOP [C3.0050]
• IRB Application “Form T” (Research Involving Adults with Impaired Consent Capacity) [Web-Based Tool to determine research risk level and likelihood of consent impairment] [F1.1450]
• IRB Application Instructions for “Form T” [F1.1500]
• Assessing Consent Capacity in Clinical Research: New Directions [D95.0000] (PDF)
• Advice to Legally Authorized Representatives of Adult Participants in Medical Research [D87.0000] (PDF)
• Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [D88.0000] (PDF)

Informed Consent/Assent

Informed Consent/Assent - Comprehensive webpage that provides additional tools and information on developing Informed Consent and the Informed Consent Process. 

• Informed Consent SOP [C3.0050]

International & Non-English Speaking Subjects

• IRB Application Instructions - Non-English, Foreign Culture (recruitment of Non-English speaking subjects) [F1.0500]
• Single IRB Reliance/Off-Site
• OHRP International Issues
• NIH ClinRegs: Clinical research regulations from around the globe
• 2023 FDA Informed Consent Guidance [HTML]

Investigator/Research Staff Responsibilities

Researchers - Comprehensive webpage that provides additional tools and information for Researchers and research support staff.

Select Forms/Guidance:

• A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [D9.0000] (PDF)
• OHRP Investigator Responsibility Frequently Asked Questions
• FDA Guidance for Industry: Investigator Responsibilities (PDF)
• Investigator Qualifications and Provision of Medical Oversight [D128.0000] (PDF)

Investigators Who Are Also Considered Sponsors

• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [D44.0000] (PDF)
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [D45.0000] (PDF)

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Modification Requests

Modification Requests - Comprehensive webpage that provides additional tools and information on developing a Modification Request.

Select Forms/Guidance:

• Modification - IRB Review of Changes SOP [C2.0300]
• Modification Reviewer Signature Page [F29.0000] (PDF)

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Pregnant Women, Fetuses, & Neonates (Vulnerable Subjects)

Research Involving Pregnant Women, Fetuses, and/or Neonates - A comprehensive webpage that provides additional tools and information on research involving pregnant women, fetuses, and/or neonates.

• Protection of Vulnerable Subjects SOP [C3.0100]
• IRB Application “Form U” (Research Involving Pregnant Women, Fetuses, &/or Neonates) [F1.1550] (PDF)
• Summary of Pregnant Women, Fetuses, & Neonates Regulations 45 CFR 46 Subpart B [D64.0000] (PDF)

Prisoners (Vulnerable Subjects)

Research Involving Prisoners [F1.1700] - A comprehensive webpage that provides additional tools and information on research involving prisoners.

• Protection of Vulnerable Subjects SOP [C3.0100]
• IRB Application (Research Involving Prisoners "Form V") [F1.1650] (PDF)
• Prisoner Representative Reviewer Signature Form [F23.0000] (PDF)
• OHRP Prisoner Frequently Asked Questions
• KY Department of Corrections (DoC) Policies and Procedures: Research, Surveys, and Data Requests (PDF)
• OHRP Guidance on the Involvement of Prisoners in Research – 5/23/03 [T22.0000]
• Research Involving Prisoners Flow Chart [T23.0000] (PDF)
• 45 CFR Part 46 Waiver of the Applicability of Certain HHS Provisions for HHS Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects [T24.0000]

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Quality Improvement Program

• Quality Assurance/Improvement Program for Human Research Protections (HTML)
• Quality Improvement Program Directed On-Site Review SOP [C5.0050]
• Quality Improvement Program Principal Investigator Self-Assessment Review SOP [C5.0150]
• Quality Improvement Program Administrative Assessment Review SOP [C5.0200]
• Consent/Assent Form Checklist (Essential Elements of Informed Consent) [O1.0000] (PDF)
• Basics for Easy-to-Read Informed Consent Documents [O11.0000] (PDF)

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Radiation Safety

• Radiation Safety Officer (RSO) Coordination SOP [C6.0500]  
• IRB Application Instructions: Radiation Safety [F1.1250]

Recordkeeping

Two circumstances when IRB-approved active protocols may be closed by the PI and/or the IRB [D76.0000] (PDF)

Principal Investigators (PIs)

• Study Closure SOP [C4.0200]
• A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [D9.0000] (PDF)

Institutional Review Board (IRB)

• Minutes of IRB Meetings SOP [C4.0050]
• IRB/ORI Record-Keeping SOP [C4.0250]

Recruitment of Subjects/Advertising (Also see "Students as Subjects")

• A Principal Investigator’s Guide to Identification and Recruitment of Human Subjects for Research [D7.0000] (PDF)
• IRB Application Instructions - Advertisements (Proposed advertisement(s) of any type for recruiting subjects) [F1.0750]
• Research Recruitment and Advertising in Human Research (Video, ~15 minutes)
• E-9: Compensation to Research Subjects
• E-7.7: Payments to Foreign Nationals
• Finder's Fees - University of Kentucky Medical IRB Policy [D25.0000] (PDF)

Reportable Diseases/Conditions

• Reporting Requirements for Diseases and Conditions in Kentucky [E2.0000] (PDF)
• Protection of Human Subjects in Research Involving HIV Testing [D65.0000] (PDF)

Reporting Requirements (Unanticipated Problem/Safety Reporting, Deviation/Exception, Protocol Violation)

Principal Investigators (PIs)

• University of Kentucky Investigator Quick Guide to IRB Reporting Requirements [D109.0000] (PDF)
• Other Reviews - Comprehensive webpage that provides additional tools and information on reporting Deviations/Exceptions, Protocol Violations, and Unanticipated Problems.
• Modification - IRB Review of Changes SOP [C2.0300]
• Modification Requests: Modification of a Currently Approved Protocol [D67.0000]
• Protocol Violation Review SOP [C2.0400]
• Continuation Review SOP [C2.0250]
• Deviations and Exceptions - IRB Review of Changes [C2.0325]
• Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [C2.0350]
• IRB Policy on Unanticipated Problem and Safety Reporting to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) [D2.0000] (PDF)
• Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/NonPrompt Reporting (PDF)
• See Unanticipated Problem/Safety Reporting under Other Reviews for related forms
• Reporting Requirements for Diseases and Conditions in Kentucky [E2.0000] (PDF)

Institutional Review Board (IRB)

• Mandated Reporting to External Agencies SOP [C4.0150]
• Termination or Suspension of Research by the IRB SOP [C2.0600]
• Serious or Continuing Noncompliance or Unanticipated Problems Involving Risks: IRB Reporting to Federal Agencies [D27.0000] (PDF)

Repositories, Registries, Specimen/Tissue Banks/Genetic/Genomic Data Sharing

• UK Research Biospecimen Bank Guidance [D129.0000] (PDF)
• UK Research Registry Guidance [D130.0000] (PDF)
• Sample Repository/Registry/Bank Consent [F1.0170] (.docx)
• Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [D101.0000](PDF)
• Guidance on the NIH Genome Data Sharing (GDS) Policy [D104.0000] (PDF)
• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens [T27.0000]
• NIH Decision Chart for Research Involving Private Information or Biological Specimens [T65.0000] (PDF)
• IRB Application Guidelines and materials to submit for “Form EE” (Institutional Biosafety Committee (IBC)) [F1.2300]
• IBC/IRB/ORI Coordination SOP [C6.0100]
• Instructions for Informed Consent Documentation Relating to Genetic Information Nondiscrimination Act (GINA): Medical IRB [F1.0175] / Nonmedical IRB [F2.0175]
• DHHS - The Genetic Information Nondiscrimination Act of 2008 - Information for Researchers and Health Care Professionals [D106.0000]
• Human Genetic Research -- OHRP: IRB Guidelines, Chapter 5, Section H [T14.0000] (PDF)
• OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [D74.0000] (PDF)
• FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [T12.0000] (PDF)
• FDA Blood & Blood Products
• UK Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [D117.0000] (PDF)
• HIPAA and Research Repositories
• NIH Genomic Data Sharing (GDS) Policy

Return of Research Results or Incidental Research Findings

• Frequently Asked Questions (FAQs) on the Return of Research Results or Incidental Research Findings [D118.0000] (PDF)
• Single-Subject Consent to Receive or Refuse Result or Incidental Finding - Sample Consent [D119.0000] (Coming Soon)
• The MRCT Center of Brigham and Women's Hospital and Harvard: Return of Individual Results
• National Academies of Science, Engineering & Medicine Consensus Study Report: Returning Individual Research Results to Participants

Risk Assessment

University of Kentucky Research Risk Assessment Guidance [D8.0000] (PDF)

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Students as Subjects (Vulnerable Subjects)

• Protection of Vulnerable Subjects SOP [C3.0100]
• Guidance for Enrolling University Students as Research Subjects [D4.0000] (PDF)
• Considerations for the IRB when reviewing protocols from College of Education Early Childhood, Special Education and Counselor Education program (PDF)
• K-12 Teacher & Support Staff HSP Training Course
• IRB Application Information for “Form II” (Medical Center and/or College of Medicine residents or fellows as research subjects) [F1.2500]
• Guidance for Enrolling K-12 Students as Research Subjects [D79.0000] (PDF)
• Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000] (PDF)
• U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [D60.0000] (PDF)

Study Closure

• Study Closure SOP [C4.0200]
• Two circumstances when IRB-approved active protocols may be closed by the PI and/or the IRB [D76.0000] (PDF)

Study Personnel

• What Constitutes Study Personnel on a Protocol Involving Human Subjects? [D28.0000] (PDF)
• Adding Non-UK Study Personnel [D163.0000] (PDF)

Single IRB Reliance

Single IRB Reliance - Comprehensive webpage that provides additional tools and information on Single IRB Reliance.

Suicidality and Research Ethics

Suicide Ideation or Behavior Among Research Participants (PDF)

Survey Research

Survey Research - Comprehensive webpage that provides tools and information for researchers conducting survey research.

• Informed Consent for Survey Research

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